The Application of Hyperbaric Oxygen Therapy in Non-ventilated COVID-19 Patients - Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Oxygenation Index
研究概览
简要总结
This study is a prospective randomized controlled, double blind clinical trial performed on laboratory confirmed COVID-19 infection admitted patients in the Shamir Medical Center. The trial will include 30 patients who will undergo either hyperbaric oxygen therapy (HBOT) or Normobaric oxygen therapy (NBOT), randomized on a 2:1 ratio, within 4 days in addition to the standard treatment including oxygen, drugs, steroids, bronchodilators, antibiotics and others.
The evaluation procedure includes symptom monitoring, room air saturation, vital signs monitoring, pulmonary function and blood tests at baseline, one day and one week after the last session. In addition, one hour prior to and post session saturation and vitals will be monitored.
详细描述
This study is a prospective randomized controlled, double blind clinical trial performed on laboratory confirmed COVID-19 infection admitted patients at MMC. The trial will include 30 patients who will undergo either HBOT or NBOT, randomized on a 2:1 ratio, within 4 days in addition to the standard treatment including oxygen, drugs, steroids, bronchodilators, antibiotics and others.
Sessions will be provided in an MMC monoplace HBO chamber (RestorixHealth). Since all patients demand oxygen supply at room air, the control group is an active arm receiving 100% oxygen. For HBOT, each session will include breathing 100% oxygen at 2.2 absolute atmospheres (ATA) for 60 minutes. Compression and decompression will occur at 1 meter/minute rate. For NBOT, each session will include breathing 100% oxygen at 1.0 absolute atmospheres (ATA) for 60 minutes. In order to blind the patient, the first 5 minutes will include compression for 1.1 ATA and then decompression to 1.0 within the next 5 minutes.
During the sessions, the symptoms and vitals will be monitored. The evaluation procedure will include symptom monitoring, room air saturation, vital signs monitoring, pulmonary function and blood tests at baseline, one day and one week after the last session. In addition, one hour prior to and post session saturation and vitals will be monitored. Sessions and evaluations procedures will occur as the following:
Protocol Day 1
- Baseline evaluation: blood test including: arterial blood gases, 2 CBC tubes, 2 Gel tubes (10-15 cc total), vitals (temperature, blood pressure, heart rate, room air saturation), symptoms questionnaire, pulmonary function test.
- Vitals (temperature, blood pressure, heartrate, room air saturation) one hour prior to session
- One-hour session NBO/HBO
- Vitals (temperature, blood pressure, heartrate, room air saturation) one hour after the session.
- Vitals (temperature, blood pressure, heartrate, room air saturation) one hour before the 2nd session.
- One-hour session NBO/HBO (8 hours following the first session)
- Vitals (temperature, blood pressure, heartrate, room air saturation) one hour after the session.
- Daily oxygen supply dose monitoring. Protocol Day 2-4
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Within 7 days of patient's need of oxygen supply
- •Positive SARS-CoV-2 RT-PCR
- •At least one risk factor for bad prognosis of COVID-19: hypertension, diabetes mellitus, ischemic heart disease, smoking, age>50, etc.
- •Respiratory insufficiency: Room Air SpO2 <94% or PaO2/FiO2<300mmHg
- •Ability to sign an informed consent
排除标准
- •Negative SARS-CoV-2 RT-PCR
- •HBOT contraindication: pneumothorax, pneumomediastinum, claustrophobia, ear/sinus disease which aren't allowed in HBOT, known chronic pulmonary disease: severe emphysema or known pulmonary bullae.
- •Pregnancy
- •Inability to sign an informed consent
结局指标
主要结局
Oxygenation Index
时间窗: one day after the last session
PaO2/FiO2 (Oxygenation Index)
次要结局
未报告次要终点